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Tackling Barriers to Clinical Trials Participation

by Blair Burnett, ACCC Policy Analyst

April 18, 2018

A reportreleased last week at the American Cancer Society Cancer Action Network (ACS CAN) annual national policy forum in Washington, D.C., finds that only 27 percent of patients have access to clinical trials close to where they are receiving treatment. In this new landscape report, “Barriers to Patient Enrollment in Therapeutic Clinical Trials for Cancer,” existing key research and knowledge on barriers to trial participation are brought together and analyzed to better understand how these barriers relate to each other, as well as how each contributes to the problem. ACS CAN offers the report as a resource for discussions and action steps for tackling barriers to patient enrollment in clinical trials. With the report’s research as a foundation, ACS CAN has developed a set of 23 consensus recommendations for reducing barriers to clinical trial participation.

A panel session held in conjunction with the report’s release addressed three overarching barriers cited in the report: provider and institutional barriers to enrollment, patient barriers to enrollment, and clinical trial-related barriers to enrollment.

“The question should be: How do we bring a clinical trial to a patient, rather than how do we bring a patient to a clinical trial,” said panelist Jennie Crews, MD, MMM, FACP, ACCC Past President and current medical director of research integration, Seattle Cancer Care Alliance Network. Joining Dr. Crews on the panel were Janie K. Hofacker, RN, BSN, MS, Association of American Cancer Institutes (AACI) and Barbara Lubejko, RN, MS, Oncology Nursing Society (ONS). The discussion, moderated by Brad Hirsch, MD, of SignalPath, explored provider and institutional barriers in patient access to clinical trials.

From their tenure in practice at cancer programs, panelists described three sources of institutional tension contributing to barriers to trial enrollment: staffing, availability of proper infrastructure and tools, and overall funding challenges.

The panel decisively agreed that without dedicated, in-house research staff at a cancer program, there is not a viable platform to increase patient enrollment in clinical trials. Considering the dual knowledge needed for clinical trial implementation, i.e., both clinical and research, not all cancer programs across the country have the required resources for a vigorous clinical trials program. Lack of appropriate resources—specifically in terms of overall program infrastructure and essential data tools for clinical trial implementation—are barriers for many programs. Having a data tool and the requisite infrastructure are foundational to efficient, effective trial implementation, panelists said. With these resources, cancer programs can not only match potential patients with an available trial but also centralize certain regulatory processes.

An ideal tool would “circumvent all burdensome processes” to create a clinical trial network among academic and non-academic centers across the country, panelists agreed. They were unanimously optimistic that creation and deployment of such a tool would allow smaller and more rural cancer programs to stay connected and offer patients access to clinical trials close to home—despite the continued strain on rural cancer care delivery.

Even while innovation was being discussed, each panelist noted that funding and overall institutional knowledge were among the greatest barriers to clinical trial deployment. “Clinical trials and cancer care. . . providers don’t always view this as the same thing,” said Barbara Lubejko, RN, MS. “Until we view clinical trials as an integral part of cancer care, we won’t be able to move that needle.”

Dr. Crews agreed and highlighted the need to allow providers to have “time” available so that programs across the country could foster interest and engagement in clinical trials. Indeed, the panel noted that for providers, clinical trial interest is not often incentivized. Considering the deployment of certain quality measures within alternative payment models, specifically the CMMI Oncology Care Model (OCM), the panelists saw potential for a future pathway for clinical trial participation incentivized through value-based care.